[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559990":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":32,"centralContacts":37,"locations":11,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":11},{"fullName":5,"class":6},"Herbolab India Pvt. Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Destress and Perform Capsule-U001","EXPERIMENTAL",null,[13],"Other: Destress and Perform Capsule-U001",{"label":15,"type":10,"description":11,"interventionNames":16},"Destress and Perform Capsule-I001",[17],"Other: Destress and Perform Capsule-I001",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo capsules 002","OTHER",[22],"Other: Placebo capsules 002",[24,27,29],{"type":20,"name":9,"description":25,"armGroupLabels":26,"otherNames":11},"Two Capsules in sequence daily after meal for 60 days.",[9],{"type":20,"name":15,"description":25,"armGroupLabels":28,"otherNames":11},[15],{"type":20,"name":19,"description":30,"armGroupLabels":31,"otherNames":11},"Two Capsules in sequence daily after meal for 60 days",[19],[33],{"name":34,"affiliation":35,"role":36},"Dr. Ramshyam Agarwal, MBBS, DNB","Lokmanya Medical Research Centre and Hospital","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Dr. Kriti Soni, PhD","CONTACT","+91 9871018383","kriti.soni@rpsg.in",{"name":44,"role":40,"phone":45,"phoneExt":11,"email":46},"Dr. Gayatri Ganu, PhD","+91 8554912644","drgayatri@mprex.in",{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100559990","clinical-study-to-reduce-premature-ejaculation-in-healthy-adult-men-100559990",false,"NCT06571318","Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men","A Randomized, Double Blind, Placebo-controlled, Parallel Arm Clinical Trial of De-Stress and Perform Capsule in the Management of Stress-induced Premature Ejaculation in Healthy Adult Men","Inclusion Criteria:\n\n1. Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED\n2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26\n3. Participant having baseline IELT of less than 2 min\n4. Participants meeting with diagnostic criteria for PEP score greater than or equal to 11\n5. Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group\n6. Participants should be in an active stable sexual relationship only married participants for the entire duration of the study\n7. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Previous events or other severe conditions that may affect premature ejaculation\u002Ferectile dysfunction, including but not limited to spinal trauma or pelvic surgery\n2. Participants with genital anatomical deformities, including but not limited to penile deformities\n3. Participants for whom sexual activity is inadvisable because of their underlying disease status\n4. Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals\n5. Presence or history of any of the following disorders\u002Fdisease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders\n6. Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs;\n7. Participants with history or presence of significant alcoholism or drug abuse within the past 1 year\n8. Participants with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco\u002Fnicotine products more than 10 times per day\n9. Any concomitant treatment that is not permissible including but not limited to (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc).\n10. Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol\n11. Known hypersensitivity to any of the ingredients of investigational product\n12. Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceutical, or ayurvedic supplement for stress and\u002For PE management\n13. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his\u002Fher participation in, and completion of the protocol.",true,"MALE","21 Years","50 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65],"NA","The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.",[68,69],"Premature Ejaculation","Stress",[68,69],"NOT_YET_RECRUITING","2024-08-23",{"date":74,"type":75},"2024-08-26","ACTUAL",{"date":77,"type":62},"2024-09-05",{"date":79,"type":62},"2024-12-28",{"name":5,"class":6}]